MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-09 for LIPOSORBER LA-15 SYSTEM N/A manufactured by Kaneka Corporation.
[96813413]
Since the reported patient's reactions occurred before any plasma passed through the liposorber la-15 column had not yet returned to the patient, the liposorber la-15 column may not be relevant to the patient's reaction. Before the plasma separation has initiated by the apheresis machine, 300ml of the patient's blood was circulated only in the blood side of the extracorporeal circuit of the ldl-a system. Accordingly, biological reactions of the patient with the blood components contacted the extracorporeal circuit including the plasma separator might be possible. It was reported that the same ldl-a procedures for 10 times in the previous course was completed eventless, and accordingly, the physical condition of the patient on the day of the incident might possibly be contributed to the occurrence of it. We believe the reported incident is attributable not to defect or malfunction of the devices but to the patient's physiology.
Patient Sequence No: 1, Text Type: N, H10
[96813415]
The patient was a male on chronic hemodialysis complicated with arteriosclerosis obliterans (aso) whose one leg had already been amputated. The patient was admitted to the hospital this time for the amputation of his ulcerative digitus pedis, and the ldl-apheresis (ldl-a) using the liposorber la-15 system was introduced for the treatment of aso. This adverse event occurred in the first ldl-a procedure following one course of ldl-a which consists of 10 single ldl-a procedures. Just before the ldl-a started, his blood pressure (bp) was 120mmhg. Immediately after the plasma pump of the apheresis machine started, the patient fell into loss of consciousness, no response to address. His bp was unmeasurable with a spo2 of 82%. The patient was immediately disconnected out of the extracorporeal circuit, given supplementation with saline and 5l oxygen, and he regained consciousness, the bp raised to 100mmhg. The operating condition of ldl-a was same as that in the previous procedures. The patients had been prescribed with 26 drugs including antihypertension, antibiotic, etc.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002808904-2017-00002 |
| MDR Report Key | 7177458 |
| Date Received | 2018-01-09 |
| Date of Report | 2017-08-07 |
| Date of Event | 2017-08-01 |
| Date Added to Maude | 2018-01-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KAZUHIKO INOUE |
| Manufacturer Street | 2-3-18,NAKANOSHIMA, KITA-KU |
| Manufacturer City | OSAKA-CITY, 530-8288 |
| Manufacturer Country | JA |
| Manufacturer Postal | 530-8288 |
| Manufacturer Phone | 4613072 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LIPOSORBER LA-15 SYSTEM |
| Generic Name | LIPOPROTEIN, LOW DENSITY, REMOVAL |
| Product Code | MMY |
| Date Received | 2018-01-09 |
| Model Number | LA-15 |
| Catalog Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KANEKA CORPORATION |
| Manufacturer Address | 2-3-18, NAKANOSHIMA, KITA-KU, OSAKA-CITY, 530-8288 JA 530-8288 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2018-01-09 |